The Pharmacokinetic Interaction Between Celecoxib and Rebamipide

Healthy Male Volunteers Clinical Trial

Official title:

Clinical Trial to Assess the Pharmacokinetic Interaction Between Celecoxib and Rebamipide in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549743
• Other study ID #: HL-CER-101
• Status: Completed
• Phase: Phase 1
• Start date: May 9, 2012
• Est. completion date: June 13, 2012

Study information

• Verified date: August 2018
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial aims to assess the pharmacokinetic interaction between celecoxib and rebamipide in healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 13, 2012
• Est. primary completion date: June 13, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Body weight ae least 50kg and BMI(body mass index) within the range of 18 to 27kg/m2

• Agreement with written informed consent

Exclusion Criteria:

• Subject with symptoms of acute disease within 28days prior to study medication dosing

• Subject with known for history which affect on the absorption, distribution, metabolism, excretion of drug

• Subject with clinically significant active cardiovascular, respiratory, renal, endocrine, hematologic, gastrointestinal, neurologic, autoimmunologic disease or malignant tumor

• Subject with unsuitable clinical test through the medical checkup(medical history, physical examination, ECG, laboratory test) within 28days prior to study medication dosing

• Subject with any of the following findings; i. AST(sGOT) or ALT(sGPT) > 1.5 fold normal value or ii. Total bilirubin > 1.5 fold normal value

• Subject with clinically significant allergic disease (except for mild allergic rhinitis, mild allergic dermatitis seems to be not need for medication)

• Subject with known for hypersensitivity reaction to celecoxib, rebamipide, sulphonamide analog

• Subject with asthma, acute rhinitis, nasal polyp, angioedema, urticaria, allergic reaction to aspirin or any other NSAIDs(including COX-2 inhibitors)

• Subject with hereditary disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

• Use of any prescription medication within 14 days prior to study medication dosing

• Use of any medication(Over-the-counter medication, oriental medication, vitamin) within 7 days prior to study medication dosing

• Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug

• Subject who is not able to taking the institutional standard meal

• Whole blood donation within 60days, component blood donation within 20days or receiving blood transfusion within 30days prior to study medication dosing

• Participation in any clinical investigation within 60days prior to study medication dosing

• Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette > 10 cigarettes per day)

• An impossible one who participate in clinical trial by investigator's decision including for reason of laboratory test result

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• Celecoxib
Celecoxib 200mg will be administered orally twice a day for 3 days
• Rebamipide
Rebamipide 100mg will be administered orally three times a day for 3 days
• Celecoxib plus Rebamipide
Celecoxib plus Rebamipide same way as "arm: celecoxib" and "arm: rebamipide"

Locations

Country	Name	City	State
Korea, Republic of	The Korea Univertisy Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax,ss, Cmin,ss, Tmax,ss, Cav,ss, AUCt, DOF(= (Cmax-Cmin)/Cav), Swing		Day1(0hr), Day2 (0hr), Day3 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hr)